Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study

NCT00877006 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).

Interventions

  • DRUG prednisone
  • DRUG cyclophosphamide
  • DRUG rituximab
  • DRUG bendamustine
  • DRUG vincristine

Study Locations (20)

California

  • Teva Investigational Site 11 — Corona
  • Teva Investigational Site 21 — Fountain Valley
  • Teva Investigational Site 52 — Fountain Valley
  • Teva Investigational Site 64 — Fullerton
  • Teva Investigational Site 40 — Los Angeles
  • Teva Investigational Site 53 — Los Angeles
  • Teva Investigational Site 57 — San Diego

Florida

  • Teva Investigational Site 58 — Fort Myers
  • Teva Investigational Site 38 — Hollywood
  • Teva Investigational Site 23 — Jacksonville
  • Teva Investigational Site 65 — Lake Worth
  • Teva Investigational Site 156 — Miami

Colorado

  • Teva Investigational Site 15 — Aurora
  • Teva Investigational Site 155 — Denver
  • Teva Investigational Site 5 — Fort Collins

Connecticut

  • Teva Investigational Site 70 — New Britain
  • Teva Investigational Site 37 — Norwalk
  • Teva Investigational Site 67 — Southington

Arizona

  • Teva Investigational Site 165 — Tucson

Arkansas

  • Teva Investigational Site 167 — Little Rock

Trial Details

FieldValue
Enrollment Target 447 participants
Start Date 2009-04-30
Est. Completion 2012-03-31
Phase Phase 3

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00877006

The ClinicalTrials.gov registry entry for NCT00877006 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 103 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00877006 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00877006 about?

NCT00877006 is a clinical study titled "Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study". The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and predni...

What is the current status of trial NCT00877006?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2009-04-30. Estimated completion is 2012-03-31.

What conditions does trial NCT00877006 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00877006?

The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (DRUG), bendamustine (DRUG), vincristine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00877006?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 103 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00877006 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial